Diabetic Nephropathy is one of the complications of diabetes mellitus involving basement membrane thickening as a result of reduction in Heparan Sulfate, Laminin and increase in type-IV Collagen. Diabetic Nephropathy is characterized by increased excretion of albumin in the urine as a result of Glomerular Basement Membrane damage. Glomeruli become more porous to passage of macromolecules. During Diabetic Nephropathy the functional unit of kidney, the Nephrons are damaged leading to increased filtration rate and also increased excretion of proteins in urine. Therefore, compositions helpful in modulating the damaged kidney membrane have a tremendous scope in preventing the progression of Diabetic Nephropathic state.
Diet plays a major role in management of diabetic complications. Dietary fibre—unabsorbable carbohydrates in the diet has many beneficial effects including slowing macromolecular digestion, slow release and absorption of glucose etc. The dietary fibres are fermented by microbes in the colon to short chain fatty acids and the role of butyric acid—a four carbon fatty acid in particular, on various physiological functions is receiving great attention.
A reference can be made to U.S. Pat. No. 6,248,375 wherein designed solid matrix nutritional product is designed containing dietary fibre and indigestible oligosaccharides to be administered to diabetics. The draw back of this nutritional product is that it does not include butyric acid, which is recognized for its role at the molecular level.
A reference can be made to U.S. Pat. No. 4,598,081 wherein a butyric acid analogue has been recommended for the treatment of complications of diabetes mellitus. The draw back is non-usage of dietary fibre, which acts as a reservoir of butyric acid and has supplementary beneficial effect.
A reference can be made to U.S. Pat. No. 6,303,586 wherein a supportive therapy in the form of stabilized rice bran is given in the treatment of diabetes. This includes both the solubilised and insolubilised fractions of the stabilized rice bran. The draw back of this therapy is that it includes only a single type of dietary fibre (rice bran).
A reference may be made to U.S. Pat. No. 6,303,174 that concerns with the food composition including resistant starch. The draw back of this composition is that it can include only a soluble fibre from grains and legumes.
A reference can be made to U.S. Pat. No. 6,248,390 wherein fibre-water-water containing soluble fibre is invented. The draw back of this invention is that it includes only water-soluble fibre.
Hence, a pharmaceutical composition comprising butyric acid, wheat bran and guar gum has a significant role in ameliorating the increased Glomerular Filtration Rate and protein in urine and also prevent the progression of Diabetic Nephropathy.